Thermo Scientific

Basic Information

• Brand Name: Thermo Scientific
• Primary DI: 10850685007453
• Version / Model: Heraeus Cryofuge 16 Heavy Duty
• Catalog Number: 75007678
• Company Name: Thermo Electron LED GmbH
• Labeler DUNS: 537396330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-04
• Public Version: 1
• Public Version Date: 2022-10-12
• Public Version Status: New
• Public Device Record Key: 5499ffe2-9c45-4d6d-84dc-1e7d26e2ee2e

Device Description

Heraeus Cryofuge 16 HD, 380-415V, 50Hz

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use	Hematology	864.9275	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15115	Blood bank centrifuge	An electrically-powered device intended to be used in a blood donor facility to process large volumes of blood using centrifugal force, usually to separate red blood cells or platelets from plasma for subsequent patient infusion, storage, or further processing. It is typically a large stationary structure with an electric motor, a shaft, a tachometer, and speed and time controls; it also includes a rotor for mounting one of several interchangeable heads with slots to fit sample holders (tubes/bags). It may additionally have refrigeration capabilities to perform temperature-sensitive procedures.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850685007453	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]